Trials / Completed
CompletedNCT03918304
Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS
Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso; KOREA PLUS Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS).
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 923 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting according to the approved label in Korea.
Detailed description
* Primary objective: To assess safety of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea * Secondary objective: To assess efficacy of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea.
Conditions
Timeline
- Start date
- 2019-06-11
- Primary completion
- 2024-10-27
- Completion
- 2024-10-27
- First posted
- 2019-04-17
- Last updated
- 2025-10-23
Locations
10 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03918304. Inclusion in this directory is not an endorsement.